About this trial
Basal cell carcinoma (BCC) is the most common skin cancer in the Netherlands, with incidence rates continuing to rise. The current diagnostic standard combines clinical evaluation and dermoscopy, while biopsy followed by histopathological examination remains the gold standard when uncertainty about the diagnosis persists. However, biopsy is invasive, time-consuming, and costly. Line-field confocal optical coherence tomography (LC-OCT) is a non-invasive imaging technique that has emerged as a promising alternative to biopsy for BCC suspected lesions.
This retrospective study aims to evaluate the real-world clinical performance of LC-OCT in routine dermatological practice, where it has been integrated into the diagnostic work-up for BCC-suspect lesions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥18 years
LC-OCT performed as part of diagnostic evaluation between January 2025 and June 2025 at Mohs clinics in the Netherlands
Histopathological results (biopsy or excision) and/or 6-12 month clinical follow-up data available
Disqualifiers
Patients <18 years of age
Cases without histopathological confirmation or available follow-up data
Trial population
Patients with lesions clinically suspected for BCC who visited the Mohs Clinics between January 2025 and June 2025 and underwent LC-OCT imaging as part of the diagnostic work-up.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Tumor free survival
Tumor-free survival rate at 6-12 months follow-up among patients with lesion(s) clinically suspicious for BCC, who were treated based on an LC-OCT-guided diagnosis, with treatment success defined as the absence of residual or recurrent tumor.
Secondary outcomes
Diagnostic accuracy for BCC detection
Diagnostic parameters (sensitivity, specificity, positive predictive value, negative predictive value, diagnostic odds ratio) will be estimated for diagnosis made by LC-OCT (with histopathology serving as reference standard).
Treatment strategies
Descriptive evaluation of treatment strategies following LC-OCT-guided diagnosis (ie surgical, topical).
Number of performed LC-OCT scans
Descriptive evaluation: number of LC-OCT scans performed
Lesion characteristics
Descriptive: lesion characteristics (size, location)
Sponsors and contacts
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Maastricht University Medical Center
Lead sponsor
Mohs Klinieken
Collaborator
This trial is not recruiting at the moment. You can still explore other options: